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FDA 510(k)

“POINT” Kinguide Agile Hybrid Navigation System (PSHF01-000)

K-Number: K241130 · 2024-07-24

ApplicantPoint Robotics MedTech, Inc.
Decision Date2024-07-24
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

“POINT” Kinguide Agile Hybrid Navigation System (PSHF01-000) is the device name listed in this FDA 510(k) record. The listed applicant is Point Robotics MedTech, Inc.. It received FDA 510(k) clearance on 2024-07-24 under 510(k) number K241130. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the “POINT” Kinguide Agile Hybrid Navigation System (PSHF01-000)?

“POINT” Kinguide Agile Hybrid Navigation System (PSHF01-000) is a medical device that received FDA 510(k) clearance on 2024-07-24. The listed applicant is Point Robotics MedTech, Inc.. The 510(k) number is K241130.

When did “POINT” Kinguide Agile Hybrid Navigation System (PSHF01-000) receive FDA 510(k) clearance?

“POINT” Kinguide Agile Hybrid Navigation System (PSHF01-000) received FDA 510(k) clearance on 2024-07-24, under 510(k) number K241130.

Who is the listed applicant for “POINT” Kinguide Agile Hybrid Navigation System (PSHF01-000)?

The FDA 510(k) record lists Point Robotics MedTech, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for “POINT” Kinguide Agile Hybrid Navigation System (PSHF01-000)?

The FDA product code for “POINT” Kinguide Agile Hybrid Navigation System (PSHF01-000) is OLO.

Other records listing Point Robotics MedTech, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252989“POINT” Kinguide Agile Hybrid Navigation System; DRF Accessories SetK252755POINT Kinguide Agile Robotic Arm Surgical Stereotactic SystemK230087“POINT” Kinguide Agile Hybrid Navigation SystemK220241“POINT” Kinguide Robotic-Assisted Surgical System

Related Devices (Code: OLO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261410Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration Kit))Suite 201, National Innovation CentreK261205SPINEART Navigation Instrument SystemSpineart SAK262121Ion-L Navigated InstrumentsSurGenTec, LLCK261024TMINI Miniature Robotic SystemTHINK Surgical, Inc.K261113Op.n™ Spine Navigation and Robotic GuidanceEcential RoboticsK261852OTS HipOrtoma AB

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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